AllureTM Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Latitud Hip Replacement System

FDA 510(k)

FDA Class 2 ·Orthopedic

Wireless/ Wired X-Ray Flat Panel Detectors

FDA 510(k)

FDA Class 2 ·Radiology

qER

FDA 510(k)

FDA Class 2 ·Radiology

ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM MODEL ZB763812-20, ZB653012-21, ZB402012-20, ZI

FDA 510(k)

FDA Class 2 ·Dental

APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES

FDA 510(k)

FDA Class 2 ·Ophthalmic

PRE-POWDERED NITRILE EXAMINATION GLOVES

FDA 510(k)

FDA Class 2 ·Orthopedic

truSculpt flex

FDA 510(k)

FDA Class 2 ·Physical Medicine

AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor

FDA 510(k)

FDA Class 2 ·Orthopedic

Pitkar Locked Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

STAR 90

FDA 510(k)

FDA Class 2 ·Cardiovascular

VISENSIA, VISENSIA WITH ALERT

FDA 510(k)

FDA Class 2 ·Cardiovascular

VFSS IMAGER, MODEL SIS-300

FDA 510(k)

FDA Class 2 ·Radiology

DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

IMMUNE CELL FUNCTION ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

LOPEZ VALVE

FDA 510(k)

FDA Class 2 ·General Hospital